Study of LY2140023 in Schizophrenia Comparing LY2140023, Olanzapine, and Placebo

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-Blind Comparison of LY2140023, Olanzapine, and Placebo in the Treatment of Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149292
• Other study ID #: 9777
• Secondary ID: H8Y-BD-HBBD
• Status: Completed
• Phase: Phase 2
• Start date: August 23, 2005
• Est. completion date: July 17, 2006

Study information

• Verified date: August 2021
• Source: Denovo Biopharma LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic activity) in the treatment of schizophrenia.

The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score.

Description:

The primary objective of this study was to determine if LY2140023 dosed at 40 mg twice daily (BID) for 28 days was superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score. The secondary objectives of the study were to assess the safety and tolerability of LY2140023 compared with placebo and olanzapine; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in the responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS total score; efficacy of LY2140023 compared with placebo in responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS negative symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in mood and anxiety as measured by the Hamilton Anxiety Scale (HAMA) total score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the Clinical Global Impression-Severity (CGI-S); effect of LY2140023 on prolactin levels of the patients after 4 weeks of treatment; efficacy of olanzapine compared with placebo on the PANSS total score; pharmacokinetics of LY2140023 and LY404039 in patients, and to explore the relationship between exposure and efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: July 17, 2006
• Est. primary completion date: July 17, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• meet the DSM-IV criteria for schizophrenia as confirmed by modified SCID

Exclusion Criteria:

• meet the full syndromal criteria for other Axis I disorder

• have taken any depot antipsychotic within 4 weeks before screening

• are taking mood-stabilizing agents

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• LY2140023

• olanzapine

• placebo

Locations

Country	Name	City	State
Russian Federation	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Moscow
Russian Federation	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Village Nikolskoe

Sponsors (1)

Lead Sponsor	Collaborator
Denovo Biopharma LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score	The primary objective of this study was to determine if LY2140023 dosed at 40 mg twice daily (BID) for 28 days was superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scale (PANSS) total score.	28 days
Secondary	Safety and tolerability of LY2140023 compared with placebo and olanzapine	Safety parameters evaluated included physical and neurological examinations, vital signs, body weight, 12-lead electrocardiograms (ECGs), clinical laboratory tests, prolactin levels, and the record of symptoms. Other safety measures included the Barnes Akathisia Scale (BAS), Simpson- Angus Scale (SAS), and the Abnormal Involuntary Movement Scale (AIMS).	28 days
Secondary	Efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS positive symptom subset score	The secondary efficacy variables include the change from baseline in the PANSS positive symptoms subset score, the PANSS negative symptom subset score, CGI-S score, and HAMA total score. A patient will be included in the analysis if he or she has a baseline and at least one post-baseline measure.	28 days
Secondary	Efficacy of LY2140023 compared with placebo in the responder rate in the PANSS total score	Efficacy of LY2140023 compared with placebo in the responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS total score	28 days
Secondary	Efficacy of LY2140023 compared with placebo in responder rate in the PANSS positive and negative symptom subset score	Efficacy of LY2140023 compared with placebo in responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS positive and negative symptom subset score	28 days